Integrated vascular delivery system

ABSTRACT

An integrated vascular delivery system and method of use, the system including: a frame having a catheter hub that provides a first anchoring point on the patient and receives a catheter insertable in the patient to transfer fluid at an insertion site, a stabilization hub that provides a second anchoring point on the patient, at least one lateral member extending between the catheter and stabilization hubs, and a fluidic channel. The frame operates in a folded configuration in which the hubs are coupleable and an unfolded configuration in which the anchoring points are distributed around the insertion site to anchor the frame to the patient, thereby stabilizing the catheter. In some embodiments, the system further includes a septum that helps prevent fluid leakage from the catheter hub, or a needle shield that covers the distal end of a needle used during catheter insertion.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/821,680, filed 22 Nov. 2017, which is a continuation of U.S. patentapplication Ser. No. 14/267,811, filed 1 May 2014, now U.S. Pat. No.9,827,398, which is a continuation of U.S. patent application Ser. No.13/111,693, filed 19 May 2011, now U.S. Pat. No. 8,771,230, which claimsthe benefit of U.S. Provisional Application No. 61/356,776, filed 21Jun. 2010, U.S. Provisional Application No. 61/346,292, filed 19 May2010, U.S. Provisional Application No. 61/407,797, filed 28 Oct. 2010,U.S. Provisional Application No. 61/418,349, filed 30 Nov. 2010, U.S.Provisional Application No. 61/438,774, filed 2 Feb. 2011, U.S.Provisional Application No. 61/418,358, filed 30 Nov. 2010, U.S.Provisional Application No. 61/438,782, filed 2 Feb. 2011, and U.S.Provisional Application No. 61/448,318, filed 2 Mar. 2011, all of whichare incorporated in their entirety by this reference.

BACKGROUND OF THE INVENTION Field of the Invention

This invention relates generally to the medical care field, and morespecifically to an improved vascular delivery system in the intravenoustherapy field.

Description of the Related Art

Patients undergoing medical treatment often require a form ofintravenous (IV) therapy, in which a fluid is administered to thepatient through a vein of the patient. IV therapy is among the fastestways to deliver fluids and medications into the body of the patient.Intravenously infused fluids, which typically include saline, drugs,blood, and/or antibiotics, are conventionally introduced to the patientthrough a flexible catheter positioned at any of several venous routes,such as peripheral veins and central veins.

SUMMARY OF THE INVENTION

To set up IV therapy with conventional devices and methods, thecaregiver positions the catheter over the selected vein and uses aneedle within the catheter to pierce the skin and allow insertion of thedistal end of the catheter into the vein. The proximal end of thecatheter, relative to the midline of the catheter, is fixed to the endof a catheter hub that is proximal relative to the midline of thepatient. The caregiver connects the catheter to a fluid supply throughexternal tubing, including extension tubing that is typically attachedto the catheter hub and that the caregiver typically bends into aU-shape to accommodate the typical opposite positions of the catheterand IV fluid source. To avoid unscheduled IV line restarts, the catheterand tubing are typically secured against the skin of the patient withtape or similar catheter stabilization devices (CSDs) such as adhesivestabilizing pads that restrain the catheter hub.

However, these conventional devices and methods for IV therapy havedrawbacks. The extension tubing may catch on nearby obstacles duringpatient movement or caregiver manipulation, which may cause painful veinirritation and comprise the IV. Tape and other existing CSDs are notoptimal for stabilization because securing the round, rigid, and bulkycomponents such as the catheter and tubing against relative flat skincan be difficult and ineffective. Tape and other existing CSDs do notfully prevent the catheter from moving within the vein, which leads topatient-endangering complications including catheter dislodgement,infiltration (fluid entering surrounding tissue instead of the vein) andphlebitis (inflammation of the vein). Adhesive stabilizing pads tend toresult in other undesired effects, such as skin irritation and/ orbreakdown due to prolonged concentrated adhesion to the skin.Furthermore, tape and current CSDs do not prevent the catheter frompainfully and dangerously pivoting around the insertion site and movingwithin the vein.

Thus, there is a need in the medical care field to create an improvedvascular delivery system. This invention provides such an improvedvascular delivery system.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A, 1B, 2, and 3 are schematics of the integrated vasculardelivery system of a preferred embodiment;

FIGS. 4, 5A-5D, and 6A-6C are schematics of variations of the integratedvascular delivery system;

FIGS. 7A-7D, 8A, 8B, 9 and 10 are schematics of variations of mechanismsfor coupling the catheter hub and stabilization hub in the foldedconfiguration of the integrated vascular delivery system of a preferredembodiment;

FIGS. 11A-11E, 12A-12C, 13A, 13B, 14A, 14B, 15A-15E, 16A, 16B, 17A, and17B are schematics of variations of the septum in the integratedvascular delivery system of a preferred embodiment;

FIGS. 18A, 18B, 19A, 19B, 20, 21A, 21B, 22A, 22B, and 23 are schematicsof variations of the needle shield in the integrated vascular deliverysystem of a preferred embodiment; and

FIGS. 24-27 are schematics of the method of using an integrated vasculardelivery system of a preferred embodiment.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The following description of preferred embodiments of the invention isnot intended to limit the invention to these preferred embodiments, butrather to enable any person skilled in the art to make and use thisinvention.

As shown in FIGS. 1-3, the integrated vascular delivery system 100 of apreferred embodiment includes: a frame 110 having a catheter hub 120configured to receive a catheter 122, a stabilization hub 130, and atleast one lateral member 140 extending between the catheter hub andstabilization hub; and a fluidic channel 150 that fluidicallycommunicates with the catheter. The catheter hub 120 preferably providesa first anchoring point 112 on the patient and is configured to receivea catheter 122 insertable in a patient to transfer fluid at an insertionsite 102, and the stabilization hub 130 preferably provides a secondanchoring point 112′ on the patient. The frame 110 preferably operatesin a folded configuration 114 in which the catheter and stabilizationhubs may be coupled, and in an unfolded configuration 116 in which thefirst and second anchoring points are distributed around the insertionsite 102 to anchor the frame 110 to the patient, thereby stabilizing thecatheter. For instance, in a preferred embodiment the first and secondanchoring points are on opposite sides of the insertion site, such asproximal and distal to the side, or on opposite lateral sides of theinsertion site. The system 100 preferably includes a catheter 122, suchas a catheter embedded in the catheter hub 120, but may the system mayalternatively be configured to receive and/or couple to a separatecatheter before or after insertion into the patient. In someembodiments, the system may further include a septum 170 that helpsprevent escape or leakage of fluids from the fluidic channel 150. Insome embodiments, the system may further include a needle shield 190,coupled to the catheter hub and/or stabilization hub, that engages adistal portion of a needle 104 used for inserting the catheter 122 intothe patient. The system may be used to obtain access to a blood vesselof a patient, such as one undergoing intravenous (IV) therapy. Thesystem may be used to administer drugs, antibiotics, saline, blood, orany suitable fluid to a patient, and/or to remove fluid from thepatient. The system may be used to create, stabilize, and maintain an IVline at an insertion site on a peripheral vein or artery such as on thearm, hand, or leg, or for central venous access on the neck, chest,abdomen, or any suitable IV location. However, the system may be used tocreate, stabilize, and maintain any suitable catheter-based access to apatient, such as catheters for transfer of cerebrospinal fluid.

Integrated Vascular Delivery System-Frame and Fluidic Channel

The frame 110 of the integrated vascular delivery system functions tostabilize the system and the catheter on the patient. As shown in FIGS.1-3, the frame 110 preferably includes a catheter hub 120 that providesa first anchoring point 112 on the patient, a stabilization hub 130 thatprovides a second anchoring point 112′ on the patient, and at least onelateral member 140 that extends between the catheter and thestabilization hubs. In alternative embodiments of the frame 110, theframe may include any suitable number of hubs and any suitable number oflateral members, such that the frame forms an enclosed or partial,non-enclosed perimeter of any suitable shape and size around theinsertion site 102. The frame preferably allows visualization of theinsertion site of the catheter, such as by leaving an open uncoveredarea around the catheter, although alternatively the system may includea cover that is transparent, translucent, opaque, or any suitable kindof materials, that extends over the frame to cover the insertion siteand/or catheter.

The catheter hub 120 is configured to receive a catheter 122, which maybe embedded in the catheter hub and integrally part of the system, ormay be a separate catheter that is coupled to the catheter hub 120before or after insertion into the patient, such as with a snap fit intothe catheter hub 120. Alternatively, any suitable portion of the framemay be configured to receive the catheter. The catheter hub 120preferably includes a channel 124, concentrically aligned with thecatheter, that may receive a needle 104 used during insertion of thecatheter into the patient. As shown in FIG. 3, the catheter hub and/orstabilization hub may include a sensor 126 that measures a biometricparameter such as temperature, blood pressure, or pulse rate of thepatient. The sensor 126 may additionally and/or alternatively sense anysuitable parameter such as one pertaining to the fluid passing throughthe catheter, such as pH or flow rate.

The catheter hub and/or stabilization hub may have a relatively wide andthin profile, which may help distribute forces over a greater area onthe skin and decreases the chances of the patient developing skinirritations, sores, and other degradations. The thin profile may helpdecrease the risk of the risk of the hub catching or snagging on bedequipment or other nearby obstacles that could cause the catheter tomove within the vein and cause complications such as catheterdislodgement, infiltration, and phlebitis. However, the catheter andstabilization hubs may have any suitable shape. The catheter andstabilization hubs may include a rigid or semi-rigid plastic or othersuitable material, and/or softer material. For example, one or both hubsmay include a rigid core overmolded with a softer material such assilicone.

The system may further include at least one extension tube 160 and/or afluid supply adapter 162, coupled to the catheter hub 120 and/orstabilization hub 130, that delivers fluid from a fluid supply to thefluidic channel 150. The extension tube 160, which provides stressrelief if the system is jostled (such as from patient movement orcaregiver manipulations), is preferably made of flexible tubing such aspolymer tubing, but may alternatively be a passageway made of any othersuitable material. The extension tube 160 is preferably long enough toprovide stress relief if needed, but short enough to reduce the chancesof the extension tube catching or snagging on nearby obstacles. Inanother variation, the fluidic channel 150 and/or extension tube 160 maybe coiled like a spring to provide stress relief. The length of theextension tube may alternatively be any suitable length, and may dependon the specific application of the system. Other dimensions of theextension tube, such as outer diameter and inner diameter, may alsodepend on the specific application of the system. The fluid supplyadapter 162 preferably includes a connector that attaches the extensiontube to a fluid supply (e.g. pole-mounted IV bag, syringe, or pump thatsupplies fluid through tubing). The connector may be a standard femaleluer lock connector (FIGS. 5A and 5B) or Y-connector (FIGS. 5C and 5D)that commonly interfaces with conventional IV bags. Alternatively, theconnector may be any suitable male or female connector that is adaptedto interface with a fluid supply. Furthermore, the luer lock connectoror other fluid supply adapter may be coupled directly to the catheterhub and/or stabilization hub, rather than to an extension tube.

In alternative versions of the system, the system may include more thanone extension tube 160 and/or fluid supply adapter 162, to facilitatedelivering fluid from multiple fluid supplies simultaneously to thesystem. For example, in an embodiment of the system that includes twofluidic channels, the system may include a first extension tube thatdelivers a first fluid to a first fluidic channel, and a secondextension tube that delivers a second fluid to the second fluidicchannel. However, two extension tubes may useful in applicationsinvolving the administering of two separate fluids through the samefluidic channel 150 and catheter.

The lateral member 140 functions to provide structural stability to theframe 110 by stabilizing the catheter hub 120 relative to thestabilization hub 130. As shown in FIGS. 1-3, the frame preferablyincludes two lateral members 140 and 140′ that, with the catheter andstabilization hubs, form a perimeter around the catheter. The twolateral members may be approximately parallel, or may be in any crossed,non-parallel or other suitable orientation. However, as shown in FIG. 4,the frame 110 may include only a partial perimeter around the catheter,such as with one lateral member instead of two. Each lateral member 140may be flexible, such as to allow the catheter and stabilization hubs tomove relative to one another with a significant number of degrees offreedom, including displacement in the compression direction (andsubsequent displacement in the tension direction) along the axis of thecatheter, displacement in both directions along the other two axes,twisting in both directions along the axis of the catheter, and bendingin both directions along the other two axes. In particular, the lateralmember 140 may be reversibly bendable to allow the frame 110 to be in afolded configuration in which the catheter and stabilization hubs arecoupleable. One or more lateral members may be tubular. For example, thelateral member may be a generally straight, soft, and flexible hollowchannel like medical tubing, but may be any suitable structure with alumen.

The fluidic channel 150 functions to deliver fluid from a fluid supplyto the catheter, and in some embodiments, deliver fluid to and from thecatheter, such as transferring fluid removed from the patient throughthe catheter to an external reservoir. As shown in FIG. 2, at least aportion of the fluidic channel 150 may be fixed within at least one ofthe hubs and/or within a tubular lateral member. As shown in FIGS.6A-6C, at least a portion of the fluidic channel 150 may be additionallyand/ or alternatively be external to the hubs and lateral members. Forinstance, at least a portion of the fluidic channel 150 may be molded toan external surface of the catheter hub, the stabilization hub, and/ orlateral member. The fluidic channel 150 preferably includes a turnaboutportion 152 in which fluid flows in a direction different from thatwithin the catheter 122. In particular, the turnabout portion 152preferably directs the fluid flow to a direction opposite of that withinthe catheter, or in an approximately 180-degree turn. The turnaboutportion 152 of the fluidic channel 150 may be fixed or embedded withinthe catheter hub and/or stabilization hub. In one exemplary applicationof the system, the catheter is inserted in the patient such that itspenetrating end points proximally towards the heart of the patient, andthe turnabout portion of the fluidic channel 150 allows a standsupporting the IV bag or other fluid supply to be kept near the head ofa bed, or otherwise proximal to the insertion site as is typicallypracticed in patient treatment settings. The internalized fluid flowturn in the turnabout portion 152 of the fluidic channel 150 reduces thenumber of external structures that can get caught or snagged on nearbyobstacles and consequently disturb the catheter and IV setup. Anothereffect of the turnabout portion is that if external tubing in the IVsetup is pulled or caught, the turnabout portion may enable the frame110 to stabilize the catheter more effectively by causing the catheterto be pulled further into the patient. For example, in a common catheterplacement in which the catheter is placed on the forearm with its distalend pointing proximally toward the elbow of the patient, if the externaltubing is accidentally pulled posteriorly towards the patient, thetubing will in turn pull the turnabout portion of the fluidic channel150 and the catheter hub 120 toward the patient, thereby pulling thecatheter further into the blood vessel of the patient rather thandisplacing the catheter from the insertion site.

In some variations, the system may include one, two, or any suitablenumber of fluidic channels. For instance, a second fluidic channel 150may pass through a second lateral member 140. The second fluidic channel150 preferably receives a second fluid, which may be the same ordifferent from the first fluid supplied to the first fluidic channel150. As shown in FIGS. 5A-5C, the system may further include a secondextension tube 160 that supplies a second fluid to the frame andcatheter. However, as shown in FIG. 5D, the system may include only oneextension tube 160 that supplies fluid to one or multiple fluidicchannels. The fluidic channels may have separate inlets on thestabilization hub 130 (FIGS. 5A and 5C), or may share the same inlet onthe stabilization hub in which flow may be regulated with valves orother fluid control means (FIGS. 5B and 5D). In one variation, the firstand second fluidic channels preferably fluidically communicate with thesame catheter in the catheter hub 120, coupled to the catheter at thesame point (FIGS. 5A and 5B) or different points (FIG. 5C) along thelength of the catheter or channel. In this variation, the systempreferably includes a flow control system 154 that selectively restrictsflow of one or both of the fluids to the catheter and therefore to thepatient. The flow control system 154 may include one or more valves 156,such as at the extension tubes (FIGS. 5A and 5B), at the junctionbetween the fluidic channel 150 and the catheter (FIGS. 5C and 5D) orany suitable location. The flow control system may additionally and/oralternatively use pressure drops, vents, or any suitable technique forcontrolling fluid flow among the fluidic channels and catheter. The flowcontrol system may also be present in an embodiment that includes onlyone fluidic channel 150. In another variation, the first and secondfluidic channels preferably fluidically communicate with a catheter withdual lumens, such that one catheter lumen is coupled to the firstfluidic channel and another catheter lumen is coupled to a secondfluidic channel. In yet another variation, the first and second fluidicchannels fluidically communicate with separate catheters. Additionalvariations expand on these variations with three or more fluidicchannels.

As best shown in FIG. 3, the frame 110 preferably operates in a foldedconfiguration 114 in which the catheter hub 120 and stabilization hub130 may be coupled to one another and in an unfolded configuration 116in which the first and second anchoring points are distributed aroundthe insertion site. To facilitate a folded configuration, the frame 110preferably allows the catheter hub 120 and stabilization hub 130 to moverelative to one another with a significant number of degrees of freedom.In particular, the frame is preferably reversibly bendable or foldableto fold the catheter and stabilization hubs toward each other, or topass one of the hubs over and/ or under the other hub.

In the folded configuration 114, the catheter hub 120 and stabilizationhub 130 may be coupled to one another. With the catheter andstabilization hubs coupled, the hubs experience the same movementrelative to a needle 104 being passed into the catheter hub 120 andcatheter, such as during insertion of the catheter in the patient. In afirst variation, the catheter hub 120 and stabilization hub 130 may becoupled to one another by interaction of the needle 104 with thecatheter hub 120 and/or stabilization hub 130. In one example of thisvariation, as shown in FIGS. 7A-7D, the stabilization hub 130 includesan extension 132, and the catheter hub 120 may include a slot 128 orother recess that receives the extension 132, although in anotherexample the catheter hub 120 may include the extension 132 and thestabilization hub 130 may include the slot 120. The extension 132defines a through hole 134, such that when the extension 132 is insertedinto the slot 128, the through hole 134 is substantially aligned with aneedle-receiving channel 124 of the catheter hub 120. In this variation,the frame 110 may be folded into the folded configuration duringcatheter insertion into the patient by a user (e.g. medicalpractitioner) who couples the catheter and stabilization hubs togetherby passing the needle 104 through the channel 124 of the catheter hub120 and through the through hole 134 of the extension 132.Alternatively, the frame 110 may be folded and/ or the needle 104 may bepassed through the extension and slot of the hubs during manufacturing,such as during assembly and/or packaging. When the needle 104 iswithdrawn from the hubs, the hubs may be decoupled and the frame 110 maybe unfolded into the unfolded configuration. As shown in FIGS. BA and8B, the extension 132 may be retractable into the hub when the extensionis no longer needed, such as when the frame 110 is in the unfoldedconfiguration and ready for securement to the patient. The catheter huband stabilization hub may include one, two, or any suitable number ofextensions and/or slots. However, the catheter hub 120 and/orstabilization hub 130 may additionally and/ or alternatively interactwith the needle in any suitable manner (e.g., with a housing thatsurrounds the needle) to facilitate selective coupling of the catheterand stabilization hubs.

In a second variation, the catheter hub 120 and stabilization hub 130may be coupled to one another by mutually interacting a third structuralelement. For example, as shown in FIG. 9, a block 136 may couple to boththe catheter hub 120 and the stabilization hub 130 when the frame 110 isin the folded configuration. Although the block 136 is shown in FIG. 9to have a particular geometry, the block may include a switch, latch,plug, and/ or any suitable fastener or other mechanism. Removal of theblock 136 may facilitate the decoupling of the catheter hub 120 andstabilization hub, such that frame may be in the unfolded configuration.As another example, as shown in FIG. 10, a needle or needle system 104′may couple to both the catheter hub 120 and the stabilization hub 130when the frame is in the folded configuration, such as during catheterinsertion. Following catheter insertion, removal of the needle system104′ may facilitate the decoupling of the catheter hub 120 andstabilization hub.

In a second variation, the catheter hub 120 and stabilization hub 130may be coupled to one another in a slidable manner. For example, one ofthe hubs may have side grooves or channels, and the other hub may haveside ridges that slidingly engage with the grooves of the other hub whenthe frame 110 is in the folded configuration. Other examples of thisvariation may include tabs inserted into slots, or any suitablemechanism.

In a third variation, the catheter hub 120 and stabilization hub 130 maybe coupled to one another with snaps, latches, magnets, and/ or anysuitable fastener when the frame 110 is folded into the foldedconfiguration. The fastener may be a separate piece that is mutuallycoupled to the catheter and stabilization hubs. Additional variations ofthe coupling of the catheter hub and stabilization hub include variouscombinations of the above variations. Furthermore, the catheter hub andstabilization hub may be coupled in any suitable manner, with or withoutthe cooperation of the needle to help secure or lock the coupling of thecatheter hub and stabilization hub.

In the unfolded configuration 116, as shown in FIGS. 1A and 1B, thecatheter hub 120 and stabilization hub 130 are decoupled such that theframe 110 may be secured to the patient such that the first and secondanchoring points 112 and 112′ are distributed around the insertion site102 of the catheter, thereby stabilizing the catheter. The frame 110 ispreferably secured to the patient by securing the catheter hub 120 andstabilization hub 130 to the patient at the first and second anchoringpoints, respectively. However, the frame 110 may additionally and/oralternatively be secured by securing only the catheter hub 120, only thestabilization hub 130, the lateral members 140 and/or any suitableportion of the frame 110. The frame may alternatively stabilize thecatheter at anchoring points located at any suitable locations relativeto the catheter insertion site. The frame 110, when secured to thepatient, enables the integrated vascular delivery system to stabilizethe catheter more effectively than conventional catheter securementdevices that stabilize the catheter on only one side of the insertionsite, because stabilizing the catheter on two different sides of theinsertion site reduces pivoting motions of the catheter that may occurduring normal patient movement and/or caregiver manipulates of the IVsetup. The frame 110 is preferably secured to the patient with tape, butmay additionally and/or alternatively be secured with an adhesivelocated on the underside of the catheter hub and/or stabilization hub;an elastic strap; a strap fastened with fasteners such as hooks, hookand loop, or magnets; or any suitable securement mechanism.

In one alternative embodiment, as shown in FIG. 6A-6C, the frame 110includes one catheter hub, two stabilization hubs located on an oppositeside of the frame as the catheter hub, two lateral members eachconnecting the catheter and a respective stabilization hub, and afluidic channel. In this variation, each hub provides a respectiveanchoring point, such that the overall frame 110 includes threeanchoring points 112, 112′ and 112″. In other examples, the frame mayinclude any suitable number of anchoring points distributed equally orunequally around the insertion site 102. As shown in FIG. 6A, thecatheter hub 120, stabilization hubs 130, and lateral members 140 may beintegrated in a single piece. The single piece may include a single kindof material, or may include a rigid core of a first material (e.g. arigid material such as plastic) and an outer layer of a second material(e.g. soft material such as silicone) covering the rigid core.

Other variations of catheter hub, stabilization hub, and lateral memberconfigurations may be similar to that described in U.S. application Ser.No. 12/855,013 entitled “Integrated vascular delivery system”, which isincorporated in its entirety by this reference. Furthermore, the framemay include a catheter hub and a stabilization hub, but lack a lateralmember; for example, the catheter hub and stabilization hub may becoupled together in a hinged manner such that the frame can operate infolded (“closed hinge”) and unfolded (“open hinge”) configurations.

Integrated Vascular Delivery System—Septum

The catheter hub 120 preferably further includes a septum 170 thatfunctions to seal the internal channel 124 of the catheter hub 120 afterwithdrawal of the insertion needle 104 after catheter insertion, toprevent escape or leakage of blood and other potential biohazards orother fluids from the catheter hub 120. The septum 170 is preferablycoupled to the catheter hub 120, preferably disposed within an internalchannel 124 of the catheter hub, and may be concentrically aligned withthe catheter. The septum 170 is preferably coupled to the catheter hub120 and includes a primary seal 172 and a secondary seal 174. Theprimary seal 172 is an inner seal that functions as a first defenseagainst fluid escaping, and the secondary seal 174 is an outer seal thatfunctions as a second defense against fluid escaping. In someembodiments, the septum 170 may include fewer or more seals similar tothe primary and secondary seals, which may be suitable for someapplications to modify the amount of fluid leakage protection. Theseptum preferably defines a cavity 176 between the primary and secondaryseals that may contain trapped fluid that passes through the primaryseal. The cavity 176 may be larger than the diameter of the needle 104to reduce frictional force on the needle during needle insertion throughthe septum, thereby increasing the ease of passing the needle throughthe septum. However, the cavity may alternatively be closely fit, and/ormay include a material with a lower friction coefficient and/or fluidabsorbent material.

The septum 170 may include an elastomeric material, and may have adiameter slightly larger than the channel 124 within the catheter hub120, such that compression of the septum 170, when assembled in thechannel, seals the annular gap between the outer circumferential edgesof the septum and the walls of the channel within the catheter hub 120,thereby preventing fluid from escaping through the annular gap, andfurther maintaining the coupling between the septum 170 and the catheterhub 120, similar to a press fit. The septum 170 may additionally and/oralternatively include a sealant material applied to the outer edges ofthe septum to prevent passage of fluid between the septum and catheterhub walls, and/or be temporarily or permanently bonded to the catheterhub such as with sonic welding, chemical welding, or adhesive.

As shown in FIGS. 11A-11E, in a preferred embodiment, the septum 170includes a rigid core 180 and a compressible plug 188 coupled to therigid core. The rigid core is a framework that preferably includes aback wall 182 with aperture 186 and wall members 184 extending from theball wall. The back wall 182 may provide a flange that helps seat theseptum 170 within the catheter hub 120. The wall members 184 arepreferably substantially parallel, but may be in any suitable relativeorientation that defines a gap between the wall members. Thecompressible plug 188 is coupled partially or wholly around the rigidcore, covering or filling the aperture 186 and surrounding the wallmembers 184 to define a cavity 176 in a central portion of the septum.One end of the compressible plug forms the primary seal 172, and theother end of the compressible plug covering the aperture of the backwall forms the secondary seal 174. The aperture 186 of the back wallallows needle puncture access in and out of the septum cavity (and thecatheter). The rigid core 180 is preferably made of a rigid plastic suchas polycarbonate, acrylonitrile butadiene styrene (ABS) or otherstyrene, and the compressible plug 188 preferably includes anelastomeric material such as isoprene or silicone. However, the rigidcore and compressible plug may include any suitable materials. Thecompressible plug is preferably coupled to the rigid core in anovermolding manufacturing process, but may additionally and/oralternatively include other coupling mechanisms or processes such asadhesive.

In a first alternative variation, as shown in FIGS. 12A-12C, the septumis a split septum 270 that includes a split 272 along a portion of itslength. The split longitudinally divides the septum into approximatelytwo halves or other multiple portions. The split may terminate near theinner face of the primary seal 172, such that the split 272 travelsalong at least half of the length of the septum and is joined near theprimary seal, but the split may alternatively be any suitable length,including along the entire length of the septum such that the septumincludes two separate portions. As shown in FIG. 12C, when the septum270 is assembled into the catheter hub 120, the channel of the catheterhub preferably radially compresses the septum material to close thesplit, thereby forming the cavity 176 and the secondary seal 174. Thesplit septum may be manufactured through injection molding, such as witha mold having a cavity complementary to the septum shape as shown inFIG. 12B. In another example of this variation, the split may begin atthe inner primary seal and continue towards the secondary seal. In yetanother example of this variation, the septum may be splitlongitudinally along two or more lines, forming three or more splitportions.

In a second alternative variation, as shown in FIGS. 13A and 13B, theseptum is a dual grommet septum 370 that includes at least two septumpieces 372 or “grommets” placed serially within the catheter hub 120.One of the septum pieces forms the primary seal 172 and another septumpiece forms the secondary seal 174. The septum pieces 372 are preferablyimmediately adjacent to each other such that part of their interiorfaces are contacting and form a fluid-tight seal against the catheterhub wall. The interior faces of the septum pieces 372 may be chamferedor radiused to define the septum cavity 176 between the septum pieces,but the septum pieces may alternatively have any suitable geometry.Alternatively, the septum pieces may be separated by a distance, suchthat the septum cavity is at least partially formed by the walls of thecatheter hub 120. In other examples of this variation, the septum mayinclude three or more septum pieces placed serially within the catheterhub 120, such as to provide three or more seals.

In a third alternative variation, as shown in FIGS. 14A and 14B, theseptum 470 includes at least two separate septum pieces 472 and an innersleeve 474 disposed between the septum pieces. In this variation, twoseptum pieces are placed serially within the catheter hub 120, eitherdirectly adjacent to each other or separated by a distance. One of theseptum pieces forms the primary seal 172 and another septum piece formsthe secondary seal 174. The interior faces of the septum pieces 472 arepreferably adapted to receive the inner sleeve 474, such as by definingaxially aligned recesses. The inner sleeve 474 may be cylindrical andsized to fit within the recesses of the septum pieces, with an innerdiameter large enough to form a cavity 176 that accommodates thediameter of the needle 104. The inner sleeve 474 is preferably rigid,and made of a thermoplastic material or any other suitable rigidmaterial, although the inner sleeve may be made of any suitablematerial. In other examples of this variation, the septum may includemore than two septum pieces, such as further including an outersleeve-like septum part surrounding the inner sleeve.

In a fourth alternative variation, as shown in FIGS. 15A-15E, the septum570 includes a housing with first and second housing portions 574 andfirst and second septum pieces 572. In this variation, as shown in FIG.15E, the septum includes a distal half and a proximal half that issubstantially a mirrored version of the distal half, with each halfincluding a housing portion 574 and a corresponding septum piece 572. Asshown in FIGS. 15A and 15B, each housing piece includes a tapered,hourglass-shaped chamber 576 for receiving a corresponding septum piece.The taper in the chamber 576 helps reduce relative movement such astranslational movement between the septum piece 572 and the housing 574.Each housing piece may further include an external annular flange orother protrusion that helps reduce translational movement between thehousing and the catheter hub 120. The two housing pieces 574 may becoupled together and/or to the catheter hub 120 through ultrasonicwelding, epoxy or other adhesive, threads, and/or any suitable couplingmechanism. As shown in FIG. 15C and 15D, each septum piece 572preferably includes a cavity 573 that extends inward from one open endof the septum piece, and the septum pieces are preferably assembled suchthat the open ends of the septum pieces abut against each other. In thismanner, the closed ends of the septum pieces form primary and secondaryseals 172 and 174, respectively, of the septum 570, and the joined openends of the septum pieces form enclosed septum cavity 176. The housingand septum pieces are preferably combined, with a corresponding septumportion nested within (e.g. molded into or pressed into) each housingportion, and the combined housing and septum pieces are preferablymounted within the catheter hub 120.

In an alternative embodiment, the septum may have only a primary seal.In a first alternative variation of this embodiment, the septum 170 ismade of a flexible material that self-seals to form a hermetic seal onthe hub. This self-sealing septum prevents fluid from passing out of thecatheter hub 120, contributing to a closed system in which blood andother fluids will not exit the catheter hub. In a second alternativevariation, as shown in FIGS. 16 and 17, the septum 170 may be sealedwith a plug, such as a stopper or sealant material applied to the septumby a user. Before and during catheter insertion the back end of thechannel of the catheter hub may be left open (FIGS. 16A and 17A). Afterthe catheter is inserted in the patient, the user may occlude the bloodvessel (such as by applying external direct pressure), withdraw theneedle 104 from the catheter and catheter hub 120, place a plug on theback end of the catheter hub 120 to prevent fluid flow out of the hub(FIGS. 16B and 17B), and allow the blood vessel to be in fluidcommunication with the catheter (such as by releasing external directpressure on the blood vessel). The plug may include a separate stoppedplug applied to the catheter hub (FIG. 16), a sliding piece that theuser slides to gate off the back of the hub (FIG. 17), a hinged piecethat the user swings to the back of the hub, and/or any suitable septumpiece. Any of these single seal variations of the septum may be repeatedserially to form two seals (primary and secondary) or more seals.

The septum may be one or more of the embodiments and variationsdescribed above, and/or one or more of the embodiments described in U.S.Provisional Applications 61/346,292 filed 19 May 2010 and 61/407,797filed 28 Oct. 2010, which is each incorporated in its entirety by thisreference. Furthermore, the septum may be any suitable mechanism thathelps prevent escape or leakage of fluid from the catheter hub 120.

Integrated Vascular Delivery System—Needle Shield

As shown in FIGS. 18-23, the catheter hub 120 and/or stabilization hub130 may include a needle shield 190. The needle shield 190 functions toblunt, or protect the user from, the distal end of the needle 104 afterthe needle is withdrawn from the catheter and catheter hub aftercatheter insertion. The needle shield 190 helps prevent accidentalneedle sticks to the user and the transfer of biological hazards. Theneedle shield 190 is preferably coupled to the catheter hub 120 and/orstabilization hub 130, but may additionally and/or alternatively becoupled to any suitable portion of the system. The needle shield 190 ispreferably a clip such as a spring clip, but may alternatively includeany suitable blunting mechanism such as a cap. In general, duringinsertion of the catheter into the patient, the needle 104 passesthrough an inactive needle shield 190 and into the catheter (e.g., FIG.18A). After the catheter is placed in the patient, the needle 104 iswithdrawn from the catheter in a proximal direction and engages with theneedle shield 190, such as due to interaction with a needle catch 106 onthe needle 104. After the needle catch 106 engages with the needleshield, the needle shield is triggered to decouple from the catheter huband/or stabilization hub and cover or blunt the distal end of the needle(e.g., FIG. 18B). The now active needle shield 190 continues to coverthe distal end of the needle 104 as the needle is further withdrawn andremoved from the catheter hub 120. The needle catch 106 that triggersdecoupling of the needle shield 190 from the hub may be one or more ofseveral variations. In one variation, the needle catch 106 may be anannular structure around the needle body that catches on a portion ofthe needle shield 190 as the needle is withdrawn from the hub. Inanother variation, the needle catch 106 may include barbs that allowfree passage of the needle through the needle shield 190 when the needlepasses into the catheter hub 120, but catch on the needle shield 190when the needle withdraws from the catheter hub 120. Alternatively, theneedle catch 106 may be located on the needle shield 190. However, anysuitable variation of the needle catch 106 that facilitates theengagement of the needle and the needle shield 190, and thedisengagement of the needle shield from the hub, may be used.

The needle shield 190 may be configured in one or more of severalarrangements. In a first embodiment, the needle shield 190 is coupled tothe catheter hub 120. In a first variation of this first embodiment, theneedle shield is removably coupled to an internal portion of thecatheter hub 120. For example, the needle shield 190 may be coupled toan internal surface of a proximal portion of the catheter hub 120 (FIGS.18 and 20), a distal portion of the catheter hub 120 or any suitableinternal surface of the catheter hub. As shown in FIG. 18, the needleshield 190 may be coupled to an internal surface of the catheter hubrecessed within the catheter hub, or as shown in FIG. 20, the needleshield 190 may be coupled to an internal surface of the catheter hubapproximately flush with an external surface of the catheter hub, suchas adjacent to the stabilization hub when the frame is in the foldedconfiguration. As another example, the needle shield 190 may be engagedwithin the catheter hub 120 proximal to the septum 170 (FIG. 19A),and/or distal to the septum 170. As another example, the needle shieldis engaged within the septum 170 of the catheter hub (FIG. 19B), such aswithin the cavity, a slit, or other suitable receptacle within theseptum. As yet another example, the needle shield 190 may be adjacent toa flash chamber 192.

In a second variation of the first embodiment, the needle shield 190 isremovably coupled to an external portion of the catheter hub 120. Forexample, as shown in FIGS. 21A and 21B, the needle shield may interactwith the catheter hub 120 and/or the needle 104 at least three points.The needle shield may couple to the catheter hub 120 at a first point a,such as to the outside of the hub (e.g., FIG. 21A) or to notches orother receiving features on the proximal portion of the catheter hub 120(e.g., FIG. 21B). The needle shield 190 closes around the distal end ofthe needle 104 at a second point b. The withdrawal of the needle 104causes disengagement of the needle shield from the catheter hub whenneedle catch 106 engages the needle shield 190 at a third point c. Inthis example, the needle shield may be a spring clip configured suchthat when the needle catch 106 on the needle 104 engages with the needleshield during withdrawal, the engagement simultaneously triggerscontainment of the needle tip at point b and the disengagement of theneedle shield from the catheter hub. The spring clip is preferablydimensioned relative to the needle such that a distance “x”, defined asthe distance between the distal end of the needle 104 and the needlecatch 106, is approximately equal to or less than distance “y”, definedas the distance between points b and c, although the spring clip mayhave any suitable geometry. However, the needle shield may be anysuitable mechanism to blunt the needle tip outside the catheter hub.

In a second embodiment, the needle shield 190 is coupled to thestabilization hub 130. In a first variation of this embodiment, as shownin FIGS. 22A and 22B, the needle shield is removably coupled to aninternal portion of the stabilization hub, in a manner similar to thatof the first embodiment. For example, the stabilization hub may includea tab that substantially aligns with the catheter hub 120 when the frame110 is in the folded configuration. The tab may define a recess to whichan internal needle shield couples, or an external needle shield may beexternally coupled to the tab. During catheter placement, the frame 110is preferably in the folded configuration and the needle 104 passesthrough the tab, through the needle shield, and through the catheter hub120. Upon removal of the needle 104 from the catheter hub 120, theneedle shield disengages from the stabilization hub 130 and covers theneedle. Following withdrawal of the needle from the catheter hub anddisengagement of the needle shield from the stabilization hub, the frame110 may be unfolded into its unfolded configuration. In a secondvariation, the needle shield 190 is removably coupled to an externalportion of the stabilization hub, particularly when the frame 110 is inthe folded configuration, similar to the variation in which the needleshield is coupled to an external portion of the catheter hub.

Additional alternative embodiments of the needle shield include variouscombinations of the above variations of the needle shield. In otherwords, the needle shield may be inside and/or outside the catheter hub120 and/ or stabilization hub. For example, as shown in FIG. 23, theneedle shield 190 may be coupled directly to an internal portion of thecatheter hub 120 and indirectly to an external portion of stabilizationhub 130. As another example, the needle shield may be partially insideand partially outside the catheter hub, or the three-point contactneedle shield of the first embodiment may be coupled to thestabilization hub instead of the catheter hub 120. Further, the needleshield of any of these variations may be coupled to a sheath that coversat least a portion of the needle body, such that the needle blunter andsheath combination contains more than solely the distal end of theneedle.

The needle shield may be one or more of the embodiments and variationsdescribed above, and/or one or more of the embodiments described in U.S.Provisional Applications 61/418,358 filed 30 Nov. 2010, 61/438,782 filed2 Feb. 2011, and 61/448,318 filed 2 Mar. 2011, which are eachincorporated in its entirety by this reference. Furthermore, the needleshield may be any suitable mechanism that sufficiently covers and/orblunts the distal end of the needle.

Method for Using an Integrated Vascular Delivery System

As shown in FIGS. 24-27, a method 200 for using an integrated vasculardelivery system on a patient includes the steps of: providing a frame8210, wherein the frame includes a catheter hub that receives acatheter, and a stabilization hub; folding the catheter hub andstabilization hub towards one another 8220, thereby folding the frameinto a folded configuration; coupling the catheter hub and stabilizationhub to one another 8222; inserting the catheter into the patient at aninsertion site 8230; unfolding the frame such that the frame surroundsthe insertion site in an unfolded configuration 8250; and securing theframe to the patient at a plurality of anchoring points distributedaround the insertion site 8260, thereby stabilizing the catheterrelative to the insertion site.

As shown in FIG. 24A, the step of providing a frame 8210 preferablyincludes providing an integrated vascular delivery system similar tothat described above, although any suitable frame with a catheter huband stabilization hub may be used. For example, a suitable integratedvascular delivery system may include a frame with a catheter hub and astabilization hub coupled together with a hinged joint. Furthermore, theintegrated vascular delivery system may include fewer hubs.

The step of folding the catheter hub and stabilization hub towards oneanother 8220 functions to expose the end of the catheter, which may helpprovide visual and/or physical clearance for the catheter to bepositioned at an insertion site. As shown in FIG. 24B, folding thecatheter hub and stabilization hub towards one another thereby folds theframe into a folded configuration. The folding step 8220 may includepassing the stabilization hub towards a relatively stationary catheterhub, passing the catheter hub towards a relatively stationarystabilization hub, or simultaneously passing both the catheter andstabilization hubs towards each other. In one example of the foldingstep 8220, the stabilization hub is positioned to be a proximal portionof the frame (relative to the patient) and the catheter hub ispositioned to be a distal portion of the frame. Relative to an insertionsite on the forearm of a patient, the stabilization hub is closer to theelbow and the catheter hub is closer to the hand. In this example, thefolding step 8220 folds the stabilization hub away from the patienttowards the catheter hub. Alternatively, the frame may be folded and/orthe needle may be inserted into the catheter prior to use such as duringmanufacturing (e.g. during assembly or packaging). In alternativeembodiments, the catheter hub and stabilization hub may be moved in anysuitable relative motion, such as sliding or twisting relative to eachother.

The step of coupling the catheter hub and stabilization hub to oneanother 8222 functions to secure the frame in the folded configuration.As shown in FIG. 24B, coupling the catheter hub and stabilization hub8222 may include inserting a portion of one of the catheter andstabilization hubs into the other of the catheter and stabilizationhubs. For example, inserting a portion of one of the hubs may includeinserting an extension of at least one of the hubs into a slot or otherrecess of another hub. However, in other variations, coupling thecatheter hub and stabilization hub may include engaging the hubs in aslidable manner, activating a latch, or any suitable coupling mechanism.

Inserting the catheter into the patient at an insertion site 8230functions to establish a conduit through which fluid can be administeredto or transferred from the patient. As shown in FIG. 24C-E, insertingthe catheter 8230 preferably includes inserting a needle into thecatheter hub, passing the needle telescopically through the catheter,penetrating the insertion site with the needle, positioning the catheterwithin the insertion site 8234, and withdrawing the needle from thecatheter 8236. In one variation, inserting the needle into the catheterhub includes passing the needle through the extension 8232 (theextension of one of the hubs received by another hub in step 8222),thereby locking the catheter and stabilization hubs.

In one variation, as shown in FIGS. 25A-D, inserting the catheter 8230may further include engaging at least a distal portion of the needlewith a needle shield 8240 coupled to the catheter hub and/orstabilization hub. The needle shield preferably functions to cover thedistal end of the needle and may a spring clip, cap, or any suitablemechanism. The needle shield may be inside or outside the catheter hub,inside or outside the stabilization hub, or coupled to any suitable partof the frame. In this variation, inserting the catheter may furtherinclude decoupling the needle shield 8242 from the catheter hub and/ orstabilization hub before, simultaneously with, or after, withdrawing theneedle from the catheter hub 8236. The action of the needle insertionand/or needle withdrawal may trigger the decoupling of the needle shieldfrom the catheter hub and/or stabilization hub. In this manner, theneedle may be fully withdrawn from the catheter hub while still beingengaged and/or covered with the needle shield.

Unfolding the frame 8250 functions to orient the frame around theinsertion site in an unfolded configuration. As shown in FIG. 24F,unfolding the frame 8250 preferably reverses the movement performed onthe catheter hub and stabilization hub in the step of folding the frame8220, but may additionally and/or alternatively include other suitablesteps such as moving the catheter hub and stabilization hub in anotherdirection, twisting a portion of the frame, or sliding a portion of theframe.

Securing the frame to the patient 8260 at a plurality of anchoringpoints distributed around the insertion site functions to stabilize theframe, and thereby the catheter, relative to the insertion site.Securing the frame includes securing the catheter hub at a firstanchoring point and securing the stabilization hub at a second anchoringpoint. As shown in FIGS. 24G and 26, the first and second anchoringpoints are distributed around the insertion site, preferably onsubstantially opposite sides of the insertion site. More preferably, asshown in FIG. 27, one of the anchoring points is proximal to theinsertion site and another anchoring point is distal to the insertionsite. However, the first and second anchoring points may be distributedaround the insertion site in any suitable manner. In one variation,securing the frame may further include securing the frame at a thirdanchoring point, such that the first, second and third anchoring pointsare distributed around the insertion site. The frame may also be securedto the patient at four or more anchoring points. The multiple anchoringpoints may be approximately equally or unequally distributed around theinsertion site. The securing steps may include taping the frame to thepatient (e.g. with medical tape or sterile adhesive dressing), adheringthe frame to the patient with adhesive, strapping the frame to thepatient, or any suitable securing mechanism.

As shown in FIG. 24G, the method may further include applying a septumplug 8270, preferably to a proximal portion (e.g. needle-receivingchannel) of the catheter hub, which functions to help prevent escape orleakage of fluids from the catheter after the catheter insertion. Theseptum plug may be applied in one or more several manners depending onthe nature of the plug, and applying a septum plug 8270 may includesliding a septum plug over the catheter hub (e.g. septum is a slidinggate), stopping a channel in the catheter hub (e.g. septum is astopper), or any suitable steps.

As shown in FIG. 26, the method may further include the step of applyinga dressing over the insertion site and the frame 8280. The step ofapplying a dressing functions to protect the insertion site againstbacteria, viruses, and other pathogens. The dressing is preferably abreathable, sterile dressing. The dressing is preferably transparent toallow visualization of the insertion site, and includes adhesive toattach to the skin of the patient and to provide securement of theframe. The dressing can be used after the frame has been secured to thepatient, or the dressing can be used to secure the frame to the patient.However, the dressing can include any suitable device or method toassist in the protection of the insertion site.

As a person skilled in the art will recognize from the previous detaileddescription and from the figures and claims, modifications and changescan be made to the preferred embodiments of the invention withoutdeparting from the scope of this invention defined in the followingclaims.

1.-20. (canceled)
 21. An integrated vascular delivery system adapted tofacilitate insertion of a catheter into a patient at an insertion site,comprising: a frame including: a catheter hub coupled to the catheter, astabilization hub, a first flexible lateral member defining a lumen andextending from a distal region of the catheter hub to a proximal regionof the stabilization hub, a fluidic channel configured to pass throughthe catheter hub, wherein the fluidic channel comprises a fixedturnabout portion defined within the catheter hub, wherein the fixedturnabout portion is configured to direct fluid flow toward the distalregion of the catheter hub, and a septum coupled to the catheter hub,wherein the septum is configured to receive a needle to facilitateinsertion of the catheter at the insertion site; and a needle shieldconfigured to capture at least a portion of the needle as the needle iswithdrawn from the catheter hub.
 22. The system of claim 21, wherein theneedle shield is coupled to the catheter hub.
 23. The system of claim21, wherein the needle shield is coupled to the stabilization hub. 24.The system of claim 21, wherein the needle shield comprises a cap. 25.The system of claim 21, wherein the needle shield comprises a springclip.
 26. The system of claim 25, wherein at least a portion of thespring clip is positioned proximal of the catheter hub, and wherein thespring clip is configured to capture at least a tip of the needle. 27.The system of claim 25, wherein the spring clip is configured to becoupled to an outer region of the catheter hub.
 28. The system of claim25, wherein the catheter hub further comprises a receiving feature, andwherein the spring clip is configured to be coupled to the receivingfeature.
 29. The system of claim 21, wherein the needle shield allowsthe needle to penetrate the catheter, through the needle shield, in aninactive configuration, and covers a distal end of the needle in anactive configuration, in withdrawing of the needle from the catheter.30. The system of claim 29, wherein the needle shield is removablycoupled to the catheter hub, and configured to engage a needle catch,upon withdrawal of the needle from the catheter hub, that transitionsthe needle shield from the inactive configuration to the activeconfiguration.
 31. The system of claim 30, wherein the needle catchcomprises an annular structure disposed around the needle, and whereinthe needle catch is configured to engage a portion of the needle shieldupon withdrawal of the needle from the catheter hub.
 32. The system ofclaim 30, wherein the needle catch comprises barbs configured to allowthe needle to penetrate the catheter hub through the needle shield andto catch the needle shield upon withdrawal of the needle from thecatheter hub.
 33. The system of claim 21, wherein the needle shieldcomprises a needle catch.
 34. The system of claim 21, wherein the septumis configured to direct the needle into a portion of the fixed turnaboutportion and into the catheter.
 35. The system of claim 21, wherein thestabilization hub is retained in an angularly displaced positionrelative to the catheter hub.
 36. The system of claim 21, wherein thefluidic channel is configured to direct fluid flow into the fixedturnabout portion.
 37. The system of claim 21, wherein the catheter hubprovides a first anchoring point on the patient and the stabilizationhub provides a second anchoring point on the patient.